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The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.

The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.

The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.

However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:

Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)

Regarding the AI/SaMD specific questions from your prompt:

1. Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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• CO2 LASER Part:
  Fractional mode is indicated only for ablative skin resurfacing.

Non-fractional mode (Impulse mode) is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

The Fractional CO2 Laser Machine uses a CO2 laser with the emission wavelength of 10600nm to emit focal spots through a high focus lens. The target is water in skin tissue. A certain amount of thermal stripping, more thermal coagulation and obvious thermal effect are produced at the part directly penetrated by the focal spot.

The Fractional CO2 Laser Machine has two operational modes, fractional mode and impulse mode.

• Fractional mode includes three modes: normal, random and midsplit;
• Impulse mode includes three modes: single, continuous and impulse.

The Fractional CO2 Laser Machine has 5 modules: Control display panel module, Main control power module, Light guide arm module, Fan cooling module, Laser module.

The provided FDA 510(k) clearance letter describes a "Fractional CO2 Laser Machine" (K250782) and its substantial equivalence to a predicate device, the "Ilooda Fraxis CO2 Laser" (K172096).

However, the document primarily focuses on demonstrating substantial equivalence through non-clinical performance and safety comparisons rather than detailing specific acceptance criteria for a study that proves the device meets those criteria, particularly in the context of device performance outcomes for intended use. The clearance is based on the device being as safe and effective as its predicate through these comparisons and compliance with relevant standards.

Therefore, many of the requested sections regarding the study that proves acceptance criteria (especially clinical study details, ground truth, expert involvement, and reader studies) cannot be extracted from this document as such studies are explicitly stated to be not included.

Here's an analysis of what can and cannot be extracted:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Compliance)

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with recognized safety and performance standards. The "reported device performance" is presented through direct comparison with the predicate.

Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided document)

As per Section 10, "No clinical study is included in this submission," and Section 9 "Non Clinical Test Conclusion," the device relies on non-clinical testing and substantial equivalence to a predicate. Therefore, the following sections cannot be fully addressed with the provided text for a clinical study proving acceptance criteria.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable (N/A) for clinical outcomes given no clinical study was performed. For non-clinical tests, specific sample sizes (e.g., number of units tested for electrical safety, number of samples for biocompatibility) are not detailed in this summary, but are typically defined by the referenced standards.
   • Data Provenance: N/A for clinical data. For non-clinical compliance testing, the provenance is from manufacturer-conducted tests or accredited labs demonstrating adherence to international standards (e.g., IEC, ISO).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No clinical study for which ground truth would be established by experts is described.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No clinical study with adjudicated outcomes is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • N/A. Such a study would be relevant for devices involving image interpretation or AI assistance, which this laser device is not described as having.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is not an AI/algorithm-driven diagnostic device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A. For non-clinical tests, the "ground truth" is defined by the passing criteria of the referenced international standards (e.g., specific thresholds for electromagnetic compatibility, absence of cytotoxicity).

7. The sample size for the training set:

   • N/A. No algorithm or AI component requiring a training set is mentioned.

8. How the ground truth for the training set was established:

   • N/A. No algorithm or AI component requiring a training set is mentioned.

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The Muscle Stimulator Device is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks, thighs and calves.
• Improvement of muscle tone and firmness, for strengthening muscles in arms.

The Muscle Stimulator Device (model PZ-100) is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has four outputs, and two applicators perform simultaneous treatment.

The Muscle Stimulator Device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The Muscle Stimulator Device is composed of control display panel module, main control module, temperature module, treatment handle module, and fan cooling module.

The proposed device can simultaneously apply multiple treatment handles to patients, and the handles are held in place by bandages.

This document is a 510(k) clearance letter for the Muscle Stimulator Device (PZ-100). It focuses heavily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of specifications.

Crucially, there is ABSOLUTELY NO MENTION of acceptance criteria related to a study proving performance, sample sizes, expert involvement, ground truth, or MRMC studies.

The document explicitly states:

• "No clinical study is included in this submission." This means there was no study to prove the device met acceptance criteria in a clinical setting with human subjects.
• The clearance is based on "non clinical tests" to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These typically involve engineering tests, electrical safety, EMC, and biocompatibility, as listed in the "Non-Clinical Test Conclusion" section.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for proving the device meets those criteria because this information is not present in the provided document.

The document describes regulatory compliance and equivalency based on technical specifications and non-clinical testing, not on a clinical performance study with human subjects, which would typically involve the criteria you asked about (sample size, expert ground truth, MRMC, etc.).

In summary, based on the provided text, the device was NOT proven to meet acceptance criteria through a clinical performance study. Its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical testing.

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The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. Accessories include a foot switch, laser protective glasses, power cords, and a water filling funnel.

The Medical Picosecond ND: YAG Laser System is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).

I am sorry, but the provided FDA 510(k) clearance letter for the Medical Picosecond ND: YAG Laser System (PZ-6) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "No clinical study is included in this submission." (Page 11, Section 8.0 Clinical Test Conclusion)
• The "Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device." (Page 11, Section 7.0 Non-Clinical Test Conclusion) These non-clinical tests relate to compliance with various IEC and ISO standards for medical electrical equipment, laser safety, and biocompatibility, as well as software validation. These are not performance acceptance criteria for the intended use (tattoo and lesion removal) in the way you are asking.

Therefore, I cannot provide the detailed information requested in your prompt as it is not present in the provided text.

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The Diode Laser Hair Removal device is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Diode Laser Hair Removal device, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

Function module description
a. Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.
b. Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.
c. Constant current board module
The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.
d. Temperature and humidity control system
The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.
e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.

The provided document is a 510(k) summary for a Diode Laser Hair Removal device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered device. This summary is focused on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating the performance of a novel AI/ML-based device.

Specifically, the document states: "No clinical study is included in this submission." This means there is no study described that would involve test sets, ground truth, expert adjudication, or MRMC studies that are typically associated with evaluating AI-powered devices.

However, I can extract the information provided about the device's performance based on non-clinical testing for substantial equivalence:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for a novel AI device's performance. Instead, it presents a comparison to a predicate device to demonstrate "substantial equivalence." The "acceptance criteria" here are implicitly that the proposed device performs comparably or within acceptable deviations from the predicate device based on non-clinical tests and safety standards.

2. Sample size used for the test set and the data provenance:
Not applicable. The document states "No clinical study is included in this submission." The testing described is non-clinical performance and safety testing directly on the device components or system, not on patient data or clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. See point 2.

4. Adjudication method for the test set:
Not applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a laser hair removal system, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. Its performance is evaluated through non-clinical testing against established safety and performance standards relevant to a laser surgical instrument, and by comparison to a predicate device.

7. The type of ground truth used:
For non-clinical tests, the "ground truth" would be the established engineering specifications for the device and compliance with recognized international standards (e.g., IEC standards for electrical, laser, and EMC safety, ISO standards for biocompatibility). For performance aspects like spot size and energy output accuracy, the ground truth is derived from validated measurement techniques.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no training set mentioned.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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